Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors
1 other identifier
interventional
280
1 country
26
Brief Summary
The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2024
Longer than P75 for phase_1
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2024
CompletedFirst Submitted
Initial submission to the registry
February 22, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 15, 2029
September 10, 2026
September 1, 2026
4.9 years
February 22, 2024
September 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Summary of safety
The number of patients with dose-limiting toxicities, serious adverse events, treatment-emergent adverse events, physical exam findings, vital signs, laboratory tests, ECG parameters and echocardiograph
Though study completion, an average of 24 months
To determine the maximum tolerated dose (MTD) if reached or maximum administered dose (MAD) and two or more recommended doses for dose expansion (RDEs) of BL-M07D1
Determine the highest BL-M07D1 dose level at which subjects do not experience a DLT during the DLT evaluation period and highest BL-M07D1 dose administered in the event and MTD cannot be defined.
21 Days
Study Arms (3)
Experimental: Dose Escalation
EXPERIMENTALBeginning with Cycle 1, BL-M07D1 will be administered on Day 1 by (IV) infusion every 3 weeks (D1Q3W)
Experimental: Dose Finding
EXPERIMENTALBeginning with Cycle 1, BL-M07D1 will be administered on Day 1 by (IV) infusion every 3 weeks (D1Q3W)
Experimental: Dose Expansion
EXPERIMENTALBeginning with Cycle 1, BL-M07D1 will be administered on Day 1 by (IV) infusion every 3 weeks (D1Q3W)
Interventions
Drug: BL-M07D1 The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized. BL-M07D1 will be administered on Day 1 by intravenous infusion every 3 weeks. Other Names: BL-M07D1
Eligibility Criteria
You may qualify if:
- Signed the informed consent form voluntarily and agreed to follow the program requirements.
- Either sex
- Age: ≥18 years
- Life expectancy of ≥3 months
- For Dose Escalation and Dose Finding: Documented locally advanced or metastatic HER2-expressing (IHC 1+ to 3+ and/or HER2 gene amplification or activating mutation \[see Table 17-5\] in tumor specimen by ISH or NGS) solid tumor(s) not amenable to curative surgery or radiation and has received at least 2 lines of standard therapy, including adjuvant/neoadjuvant treatment, or whose cancer is considered refractory to the standard of care or for which no standard treatment is available, including:
- Cohort 1: Participants with HER2 expression in endometrial cancers
- Cohort 2: Participants with HER2 expression in cervical cancers
- Cohort 3: Participants with HER2 expression in ovarian cancers, including fallopian tube cancer and primary peritoneal cancer
- Cohort 4: Participants with HER2 expression in urothelial cancers
- Cohort 5: Participants with HER2 expression in biliary tract cancers
- Cohort 6: Participants with HER2 expression in breast cancer
- Cohort 7: Participants with HER2 expression in lung cancer
- Cohort 8: Participants with HER2 expression in gastric, esophageal, or gastroesophageal junction (GEJ) cancers
- Cohort 9: Participants with HER2 expression in other solid tumors as approved by the medical monitor Note: For indications in which a HER2-directed therapy is approved, the approved treatment is recommended although not mandated, at the discretion of the investigator.
- Agree to provide most recent existing tumor samples (formalin-fixed paraffin-embedded \[FFPE\] tissue block or slides) from primary or metastatic sites for tissue-based IHC staining to centrally determine HER2 expression (see details in Section 7.1.1).
- +27 more criteria
You may not qualify if:
- Participants who meet any of the following criteria will not be eligible for participation in this study:
- Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration
- Participants with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA)
- ≥ Grade 2 heart failure at any time, or history of myocardial infarction or unstable angina pectoris within 6 months before enrollment.
- Participants with prolonged QT interval corrected Fridericia formula (\[QTcF\]\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block
- Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis, etc. Participants with skin diseases that do not require systemic treatment (such as vitiligo, psoriasis), well-controlled type 1 diabetes, or hypothyroidism are permitted. For autoimmune conditions that are active but stable and low grade on systemic therapy, discussion with the medical monitor is required prior to screening
- Participants with other prior malignancies except for: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years prior to screening
- Participants with poorly controlled hypertension by 2 types of antihypertensive drugs (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg)
- Participants with advanced or clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease and asthma, restrictive lung disease, pulmonary hypertension, etc.
- Participants who have a history of noninfectious interstitial lung disease (ILD)/ pneumonitis that required treatment with steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- Participants with stroke or transient ischemic attack (TIA) within 6 months before enrollment
- Participants with a thromboembolic event (eg, deep vein thrombosis or pulmonary embolism) within 6 months before enrollment except for those who are clinically stable and receiving treatment with adequate anticoagulant therapy for at least 3 weeks before enrollment
- Participants with primary tumors in the central nervous system (CNS) and active or untreated CNS metastases and/or carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with the investigational product (IP). Patients on low dose corticosteroids (\<10 mg prednisone or equivalent/day) may participate
- Participants with pre-existing Grade ≥2 peripheral neuropathy
- Participants who have a history of anaphylaxis or severe hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL-M07D1
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SystImmune Inc.lead
Study Sites (26)
University of Alabama Birmingham
Birmingham, Alabama, 35294, United States
City of Hope
Duarte, California, 91010, United States
START - Los Angeles
Los Angeles, California, 90025, United States
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, 90095, United States
Cedars Sinai
Los Angeles, California, 90211, United States
Scripps Health
San Diego, California, 92121, United States
University of Miami
Miami, Florida, 33136, United States
Sarah Cannon Research Institute - Lake Nona Florida
Orlando, Florida, 32827, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912, United States
University of Illinois Cancer Center
Chicago, Illinois, 60612, United States
University of Chicago Medicine
Chicago, Illinois, 60637, United States
City of Hope - Chicago
Zion, Illinois, 60099, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institiute
Detroit, Michigan, 48201, United States
WashU - Siteman Cancer Center
St Louis, Missouri, 63110, United States
START - New Jersey
East Brunswick, New Jersey, 08816, United States
Start (Nyli)
Lake Success, New York, 11040, United States
NYU Langone Hospital - Long Island Investigational Pharmacy
Mineola, New York, 11501, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Cancer Institute (Westside)
Portland, Oregon, 97225, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Start - Dfw
Fort Worth, Texas, 76014, United States
Oncology Consultants
Houston, Texas, 77030, United States
START - San Antonio
San Antonio, Texas, 78229, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Leader
SystImmune Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2024
First Posted
March 5, 2024
Study Start
February 9, 2024
Primary Completion (Estimated)
December 15, 2028
Study Completion (Estimated)
April 15, 2029
Last Updated
September 10, 2026
Record last verified: 2026-09